Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in ā¦ (NCT07554950) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in Women and Individuals With Premenstrual Dysphoric Disorder
Canada72 participantsStarted 2026-06
Plain-language summary
Premenstrual Dysphoric Disorder (PMDD) is a cyclical mood disorder characterized by emotional, cognitive, physical, and sleep-related symptoms that occur in the days leading up to menstruation and improve shortly after menstruation begins. Although medications are commonly used to treat PMDD, many individuals experience side effects, do not benefit from medication, or prefer non-medication-based approaches. Sleep difficulties are very common in individuals with PMDD and may contribute to mood symptoms, emotional regulation difficulties, and functional impairment. Psychological interventions that focus on sleep, such as sleep psychoeducation and cognitive-behavioural strategies for insomnia, are effective in other mood and anxiety disorders but have not been well studied in PMDD. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a brief, sleep-focused psychoeducation workshop tailored for individuals with PMDD or severe premenstrual symptoms. Information collected in this study may help inform future research and may improve care for individuals with PMDD.
Who can participate
Age range16 Years
SexFEMALE
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Inclusion criteria
ā. Aged 16 and above
ā. positive screening for severe PMS and PMDD as per the Premenstrual Severity Screening Tool (PSST)
ā. experiencing sleep difficulties captured by a score of 12 or greater on the Insomnia Severity Index (ISI)
ā. reported regular menstrual cycle (average length of 25-35 days)
ā. not taking psychoactive medication or oral contraceptives or a) participants must be on a stable in dose and type for at least 8 weeks prior to the start of the study and b) medications remain stable throughout the study
ā. fluent in English, minimal grade 8 reading level to understand written materials
ā. individuals must have access to a smart phone or tablet with stable internet connection in order to complete study daily questionnaires
Exclusion criteria
ā. Severe cognitive disability that could impact the understanding of the clinical questionnaires
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What they're measuring
1
Insomnia Severity Index (ISI)
Timeframe: Throughout the duration of the study (60 days), change will be assessed weekly.
2
Actigraphy watches
Timeframe: Actigraphy watches will be worn daily for 60 days for all participants.